A Study With GB004 in Adult Subjects With Active Ulcerative Colitis (UC)

• Status: Active, not recruiting
• Trial end date: 2023-02-01
• Target enrollment: 0
• Participant gender: All

Summary

A 2-part study, comprising of a 36-week placebo-controlled period and a 24-week open-label extension period, to assess the efficacy and safety of 2 dose regimens of GB004 when added to background UC therapy of 5-aminosalicylate (5-ASA) with or without systemic steroids.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GB004, Inc.

Criteria

Inclusion Criteria:

• Adult male and female subjects aged ≥ 18 years at the time of signing the informed consent form (ICF) prior to initiation of any study specific activities/procedures.

• UC diagnosed at least 3 months prior to first dose of investigational product (IP) on Day 1.

• Currently receiving treatment for UC, on a stable dose for at least 2 weeks prior to flexible sigmoidoscopy or colonoscopy, with oral 5-ASA (eg, mesalamine, sulfasalazine) alone or with one of the following oral treatments:

1. prednisone ≤ 20 mg/day or equivalent or

2. beclomethasone ≤ 5 mg/day or

3. budesonide or budesonide multi-matrix (MMX) of ≤ 9 mg/day

Exclusion Criteria:

• Prior approved biologic therapy used for the treatment of UC.

• Diagnosis of Crohn's disease, indeterminate colitis, or pouchitis, or presence of bacterial or parasitic infection.

• Tofacitinib, oral cyclosporine, sirolimus or mycophenolate mofetil within 8 weeks of Day 1.

• Azathioprine, or 6-mercaptopurine within 1 day of Day 1.

NOTE: Other Inclusion/Exclusion criteria may apply per protocol.